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Mar 03, 2026
Sanofi's oral BTK inhibitor rilzabrutinib received orphan drug designation in Japan for IgG4-related disease and warm autoimmune hemolytic anemia, while also securing U.S. FDA breakthrough therapy designation for the rare anemia indication.
Mar 02, 2026
Japan's Ministry of Health, Labour and Welfare has granted orphan drug designation to Sanofi's rilzabrutinib for IgG4-related disease, marking the third global orphan designation for this indication based on positive phase 2 study data.
Feb 12, 2026
International researchers have identified a specific antibody mutation that causes rare but serious blood clots after adenovirus-based COVID-19 vaccines or natural adenovirus infection, providing a roadmap for safer vaccine design.
